MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE; DH CPK NG TUBES

Model Number 40-7368

Device Problems Difficult to Remove (1528); Use of Device Problem (1670); Obstruction of Flow (2423); Malposition of Device (2616); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

The sample is reported to be available but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of (b)(6) 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint comp (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.H3 other text : device not returned.

Event Description

It was reported, "nasogastric tube insertion in a 3-year-old child.The procedure went well, and a weighted, guided ch8 tube was quickly inserted.When trying to remove the guide with a catheter in place, it was impossible to pull it out, so we tried several times before finally giving in and pulling it out with force.When it came time to inject air to listen to the correct positioning of the probe in the stomach, it was impossible to inject anything.Even getting the child to drink didn't help.X-ray check ordered, showing an angled probe that went down into the oesophagus but came up in the middle of the oesophagus.The tube was subsequently removed and a new one inserted.Per additional information received on 12feb2024, ¿the nasogastric tube was not flushed with 10 ml of water before removal of the stylet/guidewire.We've already made the customer aware of the importance of flushed the tube with 10 ml of water before removal of the stylet/guidewire.¿.

Manufacturer Narrative

The product involved in the report has been returned and the investigation remains in progress at this time.All information reasonably known as of 26 mar 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE
• Type of Device: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 18825062
• MDR Text Key: 336747212
• Report Number: 9611594-2024-00025
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770460314
• UDI-Public: 00350770460314
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-7368
• Device Catalogue Number: N/A
• Device Lot Number: 30229979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Sex: Female